Digitex® Suture Delivery System

Digitex Suture Delivery System allows for fixation of native tissue or any graft material—either synthetic or biologic. Digitex is indicated for both general surgery and a variety of obstetric-gynecologic procedures, including pelvic floor repair.

The Digitex Suture Delivery System is intended to place suture with or without direct visualization. It is indicated in a variety of obstetric-gynecologic, transvaginal surgical procedures including correction of pelvic organ prolapse. The Digitex Suture Cartridges intended for use with the Digitex Suture Delivery Device hold sterile suture indicated for soft tissue approximation.

Contraindications:

The use of The Digitex System is contraindicated in patients who are not candidates for surgical procedures. The Digitex is NOT to be used in applications requiring placement of suture into bone.

The Digitex Suture Cartridge is contraindicated in patients with known sensitivities or allergies to its components.

Warnings and Precautions:

The Digitex Suture Delivery System and Digitex Suture are intended for use only by physicians with adequate training and experience. The physician should be aware of techniques, complications and hazards associated with the intended procedures. As anatomy of individual patients may vary greatly, it is important that the intended locations for suture placement are planned for each procedure and each individual patient. Adequate knot security requires the accepted surgical technique of flat, squared ties as warranted by surgical circumstance and experience of the surgeon.

Adverse Effects:

As with any instrument used for surgery, the potential complications associated with the use of the Digitex SDS to place sutures include bleeding, hematoma, Infection; injury to vessels, nerves, internal organs and/or tissue; inflammatory reaction, dehiscence, erosion, extrusion, injury to abdominal wall, peritonitis

See the device instructions for use for detailed information regarding the use and suture implant procedure, warnings/precautions, adverse reactions, prior to using this product.

For further information, call Coloplast Corp at 1-800-258-3476 and/or consult the company website at www.coloplast.us.com.

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician or properly licensed practitioner.

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